Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899881
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-07
First Post:
2023-05-24
Brief Title:
A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
Sponsor:
Brock University
Organization:
Brock University
Study Overview
Official Title:
A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to examine how to design a large-scale randomized control trial examining yoga as a way to improve positive body image in men and women across the lifespan The main questions it will answer are
Is the study acceptable to participants
Is recruitment adherence and retention adequate
Are study procedures appropriate
What is the preliminary effect of yoga on embodiment sense of connection with the body self-objectification evaluating oneself based on outer appearance rather than internal functions and body appreciation
Participants will either take part in a 10-week yoga program or a control condition where they will be asked to not change their lifestyle They will complete online questionnaires at the start middle and end of the 10-weeks
Is the study acceptable to participants
Is recruitment adherence and retention adequate
Are study procedures appropriate
What is the preliminary effect of yoga on embodiment sense of connection with the body self-objectification evaluating oneself based on outer appearance rather than internal functions and body appreciation
Participants will either take part in a 10-week yoga program or a control condition where they will be asked to not change their lifestyle They will complete online questionnaires at the start middle and end of the 10-weeks
Detailed Description:
The purposes of this pilot study are
To evaluate the feasibility and acceptability of a randomized control trial by assessing participant retention data collection procedures and adherence to engaging in a supervised Hatha yoga intervention or control group
To examine preliminary effects of a yoga intervention on embodiment self-objectification and positive body image ie body appreciation among a diverse sample of adults men and women
Specifically we will test whether a 10-week Hatha yoga program will contribute to improvements in body appreciation via a greater embodiment and b lower self-objectification This will allow us to calculate effect sizes for sample size calculations for future randomized controlled trials
Clearance from the university Research Ethics Board will be obtained prior to study commencement Participants will be recruited from community centres social media and traditional media in the Niagara Region Potential participants will contact the researcher if they are interested in participating Eligible and interested participants will be provided with a link to the baseline survey via Qualtrics where they will complete informed consent demographic information and measures of physical activity and body image Once questionnaires have been completed participants will be randomly assigned using Microsoft Excel to randomize to either the yoga or control group They will be provided with instructions for their group at this time via email They will then undergo either the 10-week yoga intervention or the control condition see below for descriptions
Participants will be asked to complete the same physical activity and body image measures during week 5 and at the end of 10 weeks via Qualtrics At the final time point participants will also be asked to complete feasibility measures eg acceptability appropriateness and feasibility of the intervention and control groups as well as a series of questions asking about their perceptions of the yoga intervention or control group Upon completion of all measures participants will be fully debriefed as to the true purpose of the study and the use of deception ie true purpose of the study related to positive body image they will then be asked to provide continuing informed consent In addition the yoga instructors will also be asked a series of questions regarding their perceptions of the yoga intervention
Yoga Intervention Participants randomized to the yoga intervention will be asked to not make changes to other aspects of their lifestyle including their regular physical activity Instructors are provided with guidelines regarding the format poses language and themes of each class but within those guidelines instructors can design their own class each week Each week there will be a theme promoting empowerment or positive body image instructors will be asked to choose specific poses mantras mudras and affirmations to reinforce the theme of that week Modifications to poses will be provided by the instructor Yoga equipment will be provided during each yoga session
Each yoga class will be audio recorded to document the content of the yoga classes to ensure guidelines for the classes are followed Attendance will be recorded at each class to track adherence
Instructors The instructors will have a minimum of two years of teaching experience with diverse populations and must be a registered yoga teacher eg RYT200CYA-RYT200 meaning they have completed a minimum of 200 hours of yoga teacher training in a Yoga Alliance FoundationCanadian Yoga Alliance recognized teacher training Clothing will be standardized across instructors and appropriate for Hatha Yoga eg yoga pants and a t-shirt or tank top Instructors will be provided with an instructor manual that outlines the basic class structure and poses themes and language The instructor will be blinded to the true study purpose Instructors will then be asked to create a sample class following the manual guidelines to teach a practice class to the research team for feedback
Language and Themes Used in a Hatha Yoga Class
Control group Participants randomized to the control group will be asked not to practice yoga for the duration of the study Participants will be informed that they can engage in their regular physical activity routines and not change any other lifestyle factors Participants in the control group will be offered one free yoga class in-person at the end of the study and offered one free pre-recorded video of a yoga class from the intervention at the end of the study
Participants A target of approximately 65 adults will be recruited based on expected dropout of 30
To evaluate the feasibility and acceptability of a randomized control trial by assessing participant retention data collection procedures and adherence to engaging in a supervised Hatha yoga intervention or control group
To examine preliminary effects of a yoga intervention on embodiment self-objectification and positive body image ie body appreciation among a diverse sample of adults men and women
Specifically we will test whether a 10-week Hatha yoga program will contribute to improvements in body appreciation via a greater embodiment and b lower self-objectification This will allow us to calculate effect sizes for sample size calculations for future randomized controlled trials
Clearance from the university Research Ethics Board will be obtained prior to study commencement Participants will be recruited from community centres social media and traditional media in the Niagara Region Potential participants will contact the researcher if they are interested in participating Eligible and interested participants will be provided with a link to the baseline survey via Qualtrics where they will complete informed consent demographic information and measures of physical activity and body image Once questionnaires have been completed participants will be randomly assigned using Microsoft Excel to randomize to either the yoga or control group They will be provided with instructions for their group at this time via email They will then undergo either the 10-week yoga intervention or the control condition see below for descriptions
Participants will be asked to complete the same physical activity and body image measures during week 5 and at the end of 10 weeks via Qualtrics At the final time point participants will also be asked to complete feasibility measures eg acceptability appropriateness and feasibility of the intervention and control groups as well as a series of questions asking about their perceptions of the yoga intervention or control group Upon completion of all measures participants will be fully debriefed as to the true purpose of the study and the use of deception ie true purpose of the study related to positive body image they will then be asked to provide continuing informed consent In addition the yoga instructors will also be asked a series of questions regarding their perceptions of the yoga intervention
Yoga Intervention Participants randomized to the yoga intervention will be asked to not make changes to other aspects of their lifestyle including their regular physical activity Instructors are provided with guidelines regarding the format poses language and themes of each class but within those guidelines instructors can design their own class each week Each week there will be a theme promoting empowerment or positive body image instructors will be asked to choose specific poses mantras mudras and affirmations to reinforce the theme of that week Modifications to poses will be provided by the instructor Yoga equipment will be provided during each yoga session
Each yoga class will be audio recorded to document the content of the yoga classes to ensure guidelines for the classes are followed Attendance will be recorded at each class to track adherence
Instructors The instructors will have a minimum of two years of teaching experience with diverse populations and must be a registered yoga teacher eg RYT200CYA-RYT200 meaning they have completed a minimum of 200 hours of yoga teacher training in a Yoga Alliance FoundationCanadian Yoga Alliance recognized teacher training Clothing will be standardized across instructors and appropriate for Hatha Yoga eg yoga pants and a t-shirt or tank top Instructors will be provided with an instructor manual that outlines the basic class structure and poses themes and language The instructor will be blinded to the true study purpose Instructors will then be asked to create a sample class following the manual guidelines to teach a practice class to the research team for feedback
Language and Themes Used in a Hatha Yoga Class
Control group Participants randomized to the control group will be asked not to practice yoga for the duration of the study Participants will be informed that they can engage in their regular physical activity routines and not change any other lifestyle factors Participants in the control group will be offered one free yoga class in-person at the end of the study and offered one free pre-recorded video of a yoga class from the intervention at the end of the study
Participants A target of approximately 65 adults will be recruited based on expected dropout of 30
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None